Melissa H. Coleman

Importance: Informed consent is a critical component of patient care before invasive procedures, yet it is frequently inadequate. Electronic consent forms have the potential to facilitate patient comprehension if they provide information that is readable, accurate, and complete; it is not known if large language model (LLM)-based chatbots may improve informed consent documentation by generating accurate and complete information that is easily understood by patients. Objective: To compare the readability, accuracy, and completeness of LLM-based chatbot- vs surgeon-generated information on the risks, benefits, and alternatives (RBAs) of common surgical procedures. Design, Setting, and Participants: This cross-sectional study compared randomly selected surgeon-generated RBAs used in signed electronic consent forms at an academic referral center in San Francisco with LLM-based chatbot-generated (ChatGPT-3.5, OpenAI) RBAs for 6 surgical procedures (colectomy, coronary artery bypass graft, laparoscopic cholecystectomy, inguinal hernia repair, knee arthroplasty, and spinal fusion). Main Outcomes and Measures: Readability was measured using previously validated scales (Flesh-Kincaid grade level, Gunning Fog index, the Simple Measure of Gobbledygook, and the Coleman-Liau index). Scores range from 0 to greater than 20 to indicate the years of education required to understand a text. Accuracy and completeness were assessed using a rubric developed with recommendations from LeapFrog, the Joint Commission, and the American College of Surgeons. Both composite and RBA subgroup scores were compared. Results: The total sample consisted of 36 RBAs, with 1 RBA generated by the LLM-based chatbot and 5 RBAs generated by a surgeon for each of the 6 surgical procedures. The mean (SD) readability score for the LLM-based chatbot RBAs was 12.9 (2.0) vs 15.7 (4.0) for surgeon-generated RBAs (P = .10). The mean (SD) composite completeness and accuracy score was lower for surgeons' RBAs at 1.6 (0.5) than for LLM-based chatbot RBAs at 2.2 (0.4) (P < .001). The LLM-based chatbot scores were higher than the surgeon-generated scores for descriptions of the benefits of surgery (2.3 [0.7] vs 1.4 [0.7]; P < .001) and alternatives to surgery (2.7 [0.5] vs 1.4 [0.7]; P < .001). There was no significant difference in chatbot vs surgeon RBA scores for risks of surgery (1.7 [0.5] vs 1.7 [0.4]; P = .38). Conclusions and Relevance: The findings of this cross-sectional study suggest that despite not being perfect, LLM-based chatbots have the potential to enhance informed consent documentation. If an LLM were embedded in electronic health records in a manner compliant with the Health Insurance Portability and Accountability Act, it could be used to provide personalized risk information while easing documentation burden for physicians.

INTRODUCTION: Despite the resurgence of early tourniquet use for control of exsanguinating limb hemorrhage in the military setting, its appropriate role in civilian emergency medical services (EMS) has been less clear. OBJECTIVE: To describe the experience of prehospital tourniquet use in an urban, civilian EMS setting. METHODS: A retrospective review of EMS prehospital care reports was performed from January 1, 2005 to December 1, 2012. Data, including the time duration of prehospital tourniquet placement, EMS scene time, mechanisms of injury, and patient demographics, underwent descriptive analysis. Outcomes data for participating receiving hospitals were also reviewed. RESULTS: Ninety-eight cases of prehospital tourniquet use were identified. The most common causes of injury were penetrating gunshot or stabbing wounds (67.4%, 66/98); 7.1% (7/98) of cases were due to blunt trauma; 23.5% (23/98) of cases were from nontraumatic hemorrhage related to uncontrolled hemodialysis shunt or wound bleeding; 45.4% (44/97) of cases were placed on a lower extremity; 54.6% (53/97) were placed on an upper extremity. Placement was successful in hemorrhage control in 91% (87/95, 95%CI: 85.9-97.3%) of cases. The average prehospital tourniquet placement time was 14.9 minutes. Half of all tourniquet placements were performed by basic life support providers. Hospital follow-up was available for 96.9% (95/98) of cases. Of these, the tourniquet was removed by EMS in 3.2% (3/95), the emergency department in 54.7% (52/95), or in the operating room (OR) in 31.6% (30/95) of the time; 46.7% (14/30) of these OR cases had a documented vascular injury needing repair. Ten deaths with hospital follow-up data were identified, none of which were due to tourniquet use. There was one case of forearm numbness potentially due to nerve injury and one case with potential vascular complication, representing an overall complication rate of 2.1% (2/95). CONCLUSION: The early use of tourniquets for extremity hemorrhage in an urban civilian EMS setting appears to be safe, with complications occurring infrequently.

PURPOSE To assess the safety and efficacy of the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor osimertinib as neoadjuvant therapy in patients with surgically resectable stage I-IIIA EGFR-mutated non–small cell lung cancer (NSCLC). PATIENTS AND METHODS This was a multi-institutional phase II trial of neoadjuvant osimertinib for patients with surgically resectable stage I-IIIA (American Joint Committee on Cancer [AJCC] V7) EGFR-mutated (L858R or exon 19 deletion) NSCLC (ClinicalTrials.gov identifier: NCT03433469 ). Patients received osimertinib 80 mg orally once daily for up to two 28-day cycles before surgical resection. The primary end point was major pathological response (MPR) rate. Secondary safety and efficacy end points were also assessed. Exploratory end points included pretreatment and post-treatment tumor mutation profiling. RESULTS A total of 27 patients were enrolled and treated with neoadjuvant osimertinib for a median 56 days before surgical resection. Twenty-four (89%) patients underwent subsequent surgery; three (11%) patients were converted to definitive chemoradiotherapy. The MPR rate was 14.8% (95% CI, 4.2 to 33.7). No pathological complete responses were observed. The ORR was 52%, and the median DFS was 40.9 months. One treatment-related serious adverse event (AE) occurred (3.7%). No patients were unable to undergo surgical resection or had surgery delayed because of an AE. The most common co-occurring tumor genomic alterations were in TP53 (42%) and RBM10 (21%). CONCLUSION Treatment with neoadjuvant osimertinib in surgically resectable (stage IA-IIIA, AJCC V7) EGFR-mutated NSCLC did not meet its primary end point for MPR rate. However, neoadjuvant osimertinib did not lead to unanticipated AEs, surgical delays, nor result in a significant unresectability rate.